FDA.reportPublic FDA data

Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30

Product NDC
63354-643
11-digit product format
633540643
Labeler code
63354
Product ID
63354-643_42ee75c3-c4a4-8a64-e063-6394a90a5796
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
OIL
Route
TOPICAL
Labeler
Edgewell Personal Care Brands LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-01
Marketing end
2027-10-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
6; 4.3 g/100g; g/100g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE6 g/100g
TITANIUM DIOXIDE4.3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
eeb3c173-b280-76e4-e053-2995a90a0e79Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63354-643-11Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF3050 g in 1 BOTTLEOIL503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63354-643HAWAIIAN TROPIC MINERAL FACE SKIN NOURISHING TINTED MILK COCONUT OIL SPF30 (TITANIUM DIOXIDE, ZINC OXIDE) OIL [EDGEWELL PERSONAL CARE BRANDS LLC]2Current NDC, Legacy NDC, 1 package rows20231024_eeb3c173-b280-76e4-e053-2995a90a0e79.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 139 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b2403-4f4a-3e77-e063-6294a90a4f0a2025-12-10Exact identifier
application number: M020
Sheer Mineral Sunscreen BarTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342b69d5-f0e1-99cd-e063-6294a90abb6e2025-12-10Exact identifier
application number: M020
Sheer Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBB MEDICAL & DERMATOLOGY INC342c3f42-c17f-f777-e063-6394a90a80582025-12-10Exact identifier
application number: M020
Lip SPFTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396d3fdd-99d8-77e8-e063-6294a90aec2f2025-12-10Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396cae82-7641-e1b2-e063-6394a90a7c072025-12-10Exact identifier
application number: M020
Solar Knight SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEMASCARENAS ENTERPRISES, INC.36c27c91-22ac-205c-e063-6294a90ab3792025-12-10Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFRANCISCO FLORES, M.D., P.A.396ce15a-06ad-4055-e063-6294a90a27fb2025-12-10Exact identifier
application number: M020
Dermablue Daily ReplenishingZINC OXIDEDermablue, P.C.308da9c9-544e-d5d1-e063-6294a90aa49b2025-12-10WarningsExact identifier
application number: M020
Recoverie Mineral MatteZINC OXIDEClear Day Acne Clinic308f41de-fb14-40f9-e063-6394a90a008f2025-12-10WarningsExact identifier
application number: M020
AL0043600 Alba Botanica VE Herbal Healing BodyCOLLOIDAL OATMEALThe Hain Celestial Group, Inc.60672feb-141f-651e-e053-2a91aa0af41d2025-12-10WarningsExact identifier
application number: M020
UV Defense me. Matte Airy-Fit SunscreenZINC OXIDEMAGNIF CO., LTD459f2b8d-453c-4dee-e063-6394a90a45092025-12-10WarningsExact identifier
application number: M020
RoC Hydration Plus SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincare45a3e250-8195-344d-e063-6294a90ae6812025-12-10WarningsExact identifier
application number: M020
ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincarebf3c1474-e353-63a5-e053-2a95a90a9b262025-12-10WarningsExact identifier
application number: M020
ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoc Skincaref161d754-0c32-2fbe-e053-2a95a90a6b472025-12-10WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242ff053-b8c0-4f90-e063-6294a90a7bb32025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORYOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.247ef1f8-ad12-4f80-e063-6394a90a3e3c2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.e810d366-0c32-5b1c-e053-2a95a90a622e2025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242b7d0e-82d8-793c-e063-6294a90a4aa32025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.eb744367-f318-e1e2-e053-2a95a90a2cc42025-12-09WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.242faaed-e85a-a1d7-e063-6294a90aea922025-12-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63354-643-116335406431150 g in 1 BOTTLE (63354-643-11) 50 g2022-10-012027-10-01NoNoCurrent